Senior Instructional Designer - Regulatory Lab Training

International Executive Service Corps; Tysons (VA); On-site; USD 85,000 - 120,000; Full time

Job summary

The Instructional Design Specialist role focuses on evaluating, updating, and developing FDA laboratory training materials to meet regulatory and national standards. You will design evidence-based, adult-focused content, develop SCORM-ready modules, and coordinate with FDA experts to ensure accessibility, governance, and timely delivery.

Responsibilities include needs assessments, developing objectives and activities, and producing comprehensive course packages aligned with FDA requirements and

Qualifications

• Demonstrated experience applying evidence-based instructional design methodologies and adult learning principles to professional, technical, scientific, or laboratory training.
• Experience conducting course evaluations, needs assessments, content-gap analyses, and instructional design reviews of existing training materials.
• Experience writing measurable learning objectives and developing active-learning, scenario-based, hands-on, or performance-based exercises and assessments.
• Experience developing instructor guides, student guides or manuals, presentations, job aids, handouts, assessments, and course-evaluation instruments.
• Ability to collaborate with scientific or technical subject-matter experts and translate complex material into clear, instructionally sound learning content.
• Ability to manage multiple course-development activities, Government review cycles, source files, and deliverables while meeting established timelines.
• Working knowledge of accessibility requirements for electronic learning materials and the ability to collaborate with Section 508 specialists during development and review.
• Strong writing, editing, communication, organization, and stakeholder-coordination skills.

Responsibilities

• Review existing laboratory course materials, including instructor guides, student manuals, presentations, guidance documents, laws, regulations, exercises, job aids, online courses, and related materials provided by FDA.
• Evaluate each course against current FDA regulations, policies, guidance, scientific standards, Regulatory and Laboratory Training System requirements, and the National Curriculum Standard for laboratory professionals.
• Conduct needs assessments with FDA subject-matter experts and project stakeholders to identify content gaps, outdated materials, instructional design deficiencies, and opportunities for electronic delivery.
• Prepare a written Course Evaluation, Status, and Recommendations Report and a Course Development Plan for each assigned course in accordance with FDA timelines and approval requirements.
• Use the ORTS Course Design Document and Instructor Guide templates to document the approved instructional approach and course content.
• Develop measurable learning objectives and organize lessons with clear introductions, objectives, content, practice activities, and summaries.
• Design active-learning, critical-thinking, hands-on, scenario-based, and performance-based activities appropriate for laboratory professionals and the course level.
• Develop complete course-material packages, including instructor guides, student guides or manuals, presentations with speaker notes, job aids, handouts, practice exercises, assessments, and course-evaluation instruments.
• Develop or support SCORM-compliant online prerequisite or pre-course modules compatible with the HHS learning management system when directed by FDA, and provide required source files and SCORM packages.
• Coordinate with FDA subject-matter experts, the COR, the designated ORTS Project Manager, accessibility staff, eLearning staff, media specialists, and applicable IT personnel throughout review, development, testing, and approval.
• Ensure presentations and visual aids follow FDA Visual Identity requirements and that materials are suitable for electronic delivery, free of copyright restrictions, and ready for Government ownership and use.
• Incorporate FDA-directed updates arising from policy, scientific, regulatory, judicial, RLTS, NCS, public-health, or emergency-response changes within assigned schedules.

Skills

Evidence-based instructional design

Adult learning principles

Course evaluations

Needs assessments

Measurable learning objectives

Active-learning design

SCORM-compliant online modules

Collaboration with SMEs

Accessibility requirements

Strong writing and communication

Tools

SCORM packages

Job description

The Instructional Design Specialist role focuses on evaluating, updating, and developing FDA laboratory training materials to meet regulatory and national standards. You will design evidence-based, adult-focused content, develop SCORM-ready modules, and coordinate with FDA experts to ensure accessibility, governance, and timely delivery.

Responsibilities include needs assessments, developing objectives and activities, and producing comprehensive course packages aligned with FDA requirements and